New Drug Application for Migraine Headache Therapy Lasmitidan
A New Drug Application (NDA) for lasmiditan (Eli Lilly and Company, Indianapolis, IN) has been submitted to the Food and Drug Administration (FDA). Lasmitidan is an investigational, first-in-class therapy for the acute treatment of migraine headaches, with or without visual aura. If approved, the drug could be the first significant innovation for this type of treatment in more than two decades.
Lasmiditan is the first and only molecule in the “-ditan” class being evaluated for this type of treatment in adults. It is structurally and mechanistically different from other approved migraine therapies and has no vasoconstrictive activity. It uses a novel mechanism of action that selectively targets 5-HT1freceptors, including those expressed in the trigeminal pathway.
The NDA for lasmiditan includes data from two phase 3, single-attack studies, SAMURAI (NCT02439320) and SPARTAN (NCT02605174). In both studies, two hours after the first dose of lasmiditan, the percentage of patients who were pain-free was significantly greater than with placebo.
Lasmiditan also met the key secondary endpoint—a significantly greater percentage of patients were free of their most bothersome symptom (MBS) compared with placebo. Patients chose their MBS from sensitivity to light, sensitivity to sound, or nausea.
Lilly also plans to submit, by the end of 2018, a supplemental Biologics License Application (sBLA) to the FDA for galcanezumab (Emgality), approved for migraine, to also be approved as a preventive treatment for episodic cluster headache. The drug is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and prevents it from binding to the receptor. There are no approved preventive treatments for episodic cluster headaches in the US.
“As a caregiver for someone living with chronic migraine, I know firsthand how disabling headache diseases can be,” said Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients (CHAMP). “We’re excited about the new innovations in the acute treatment of migraine and the preventive treatment of migraine and episodic cluster headache, and we’re thankful for Lilly’s commitment to continue to investigate and hopefully bring these important new therapeutic options to market.”